MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TITANIUM MESH IMPLANT; MESH, SURGICAL, POLYMERIC

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unknown preformed titanium mesh implants/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: oztel m., et al (2021) approach: a long-term follow-up of esthetic outcomes and complications, j oral maxillofac surg volume 79, pages 1326-1327 (australia).Https://doi.Org/10.1016/j.Joms.2021.02.004.This study aims to assess the long-term differences in scarring, cosmesis, and complications between the subtarsal and transconjunctival techniques.From june 2015 to june 2019, 243 patients underwent orbital floor reconstruction with an subtarsal approach (sta) or transconjunctival approach (tca) for a unilateral orbital floor or medial wall fracture at the royal brisbane and women¿s hospital (rbwh), queensland australia.A total of 67 participants were involved in this study.The median age of participants was 36 (interquartile range = 24).44 patients (30 males, 14 females) underwent the subtarsal and 22 synthes preformed titanium mesh were used while 23 patients (15 males, 8 females) underwent the transconjunctival approach where 15 synthes preformed titanium mesh were used.Patients were assessed on average 39 months postoperatively (range: 12-72 months).The following complications were reported as follows: subtarsal group: 6 v2 paraesthesia.3 reoperation, often due to persistent diplopia or plate malposition.2 enophthalmos.3 epiphora.6 diplopia.Transconjunctival group: 6 v2 paraesthesia 4 reoperation, often due to persistent diplopia or plate malposition.2 enophthalmos.2 epiphora.6 diplopia.This report is for an unknown synthes preformed titanium mesh.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - PLATES: TITANIUM MESH IMPLANT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12349942
• MDR Text Key: 267700658
• Report Number: 8030965-2021-06993
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1